NCT04338971

Ipsihand Device Use in Stroke Patients to Assess Functional Motor Outcomes

Ipsihand Device Use in Stroke Patients to Assess Motor Recovery of the Upper Extremity and Functional Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Neurolutions, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the impact of the Neurolutions Upper Extremity Rehabilitation System, known as IpsiHand, on improving functional motor control for post-stroke patients with hemiparesis. The Neurolutions System is a brain-computer interface (BCI) comprised of a robotic orthosis, worn on the hand and wrist, and operated by the patient's brain waves which are measured by EEG electrodes. The system also utilizes a tablet interface to provide therapy instructions to the patient.

Detailed description

Participants will complete 12 weeks of home therapy with the Neurolutions IpsiHand System. Outcomes will be based on a comparison of the patient's baseline measurements to post-therapy assessments.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	IpsiHand Therapy	The IpsiHand system utilizes a Brain-Computer Interface (BCI) to enable operation of a robotic hand exoskeleton worn on the hand and wrist as participants are guided through a rehabilitation program on a tablet. Participants will complete 12 weeks of hometherapy with the IpsiHand system. Motor function of their impaired upper extremity will be evaluated at baseline, at 4-week intervals, and 12 weeks completion of IpsiHand use.

Timeline

• Start date: 2017-05-05
• Primary completion: 2020-09-28
• Completion: 2020-10-09
• First posted: 2020-04-08
• Last updated: 2026-04-17
• Results posted: 2022-01-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study